- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight (CTOR&O), will collaborate with ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle ... Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Merck & Co. (Rahway, NJ)
- …Asset Development Teams, Early Development Teams; Product Development Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling ... 2 years experience in pharma or similar industry setting.Required:Must have experience in clinical trial development and execution; clear strategic view on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and ... for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline, quality,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... needs are met through alignment of business plans and operational need within the Therapy Area and in partnership...is preferred A minimum of 12 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …evidence, economic models, and Global Value Dossiers- Propose and implement analysis of clinical trial data for cost effectiveness models and market specific ... of key drug development processes, plans, studies, and strategies including clinical , regulatory, scientific, operational , and commercial aspects of drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Times, Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog ... in life sciences, pharma with Clinical Trials Operational Data, Clinical Operational Metrics...KPIs, KRIs and KQIs related to large scale global clinical trial end to end execution. preferredDemonstrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. Responsibilities:Study ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in...and site qualification with (study team and CRO).Contribute to operational delivery aspects of the protocol and take a… more
- Merck & Co. (North Wales, PA)
- …and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential ... (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/ operational responsibilitiesPreferredField-based… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study...the study and propose mitigation plans.Monitor study budget against trial progress and bring deviations to the Operational… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions. The Director of… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and lead the gene therapy ... milestones in launch planningMedical leadership input for cross functional partners including clinical , operations, HEOR and commercial to ensure that there is a… more
- Eisai, Inc (Nutley, NJ)
- …to meet project deliverables and timelines within GV&A projects related to both clinical trial setting and observational studies.Serve as the lead statistician ... and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data, patient registries, and observational studies) to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management and medical coding expertise to promote best practices across the Clinical Trial lifecycle.Applies GCP principles to ensure all medical coding ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality… more
- Novo Nordisk Inc. (New York, NY)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... commensurate with eperience. The Position Builds relationships and demonstrates the clinical outcome and benefits of Novo Nordisk Inc., (NNI) products. Educates… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an **Associate Director - Clinical Trial Management** to join our Oncology team as a part of our new Regeneron Cell Medicines (RCM) group. You ... collaborators, and identification of project risks and contingency planning. **As an Associate Director - Clinical Trial Management, a typical day might… more
